The DNDi mission is to develop new therapies for the most neglected diseases as a response to the blatant medical needs of patients belonging to populations amongst the poorest in the world. Because these patients lie completely outside of the global pharmaceutical market, the traditional profit-based approach cannot be implemented, resulting in the absence of any significant efforts to develop drugs for diseases such as sleeping sickness or leishmaniasis.
To profit or not to profit, that is the question...
DNDi operates through a virtual model whereby all of its R&D activities are outsourced, contributing to keep development costs under control while providing high flexibility. As a consequence of this strategic option, the development of an efficient drug development programme to address neglected diseases requires the establishment of strong agreements within the entire biomedical landscape. This allows for leverage and mobility throughout private and public sectors'resources. However, owing to the absence of foreseeable profit in the field of neglected diseases, these partnerships have to be built on different grounds. This paradigm shift relies in DNDi's capacity to identify within each organisation the key factors leading to a model of collaboration which lies outside of the customary monetary exchanges, but where each partner obtains a tangible upside through a well balanced deal.
Innovative thinking to critical issues
Since its inception, DNDi has demonstrated its capacity to successfully engage academia, public health institutes, biotech, or pharmaceutical industries. Today it manages 250 research, technical, and funding agreements with both public and private partners. However, the successful conclusion of these agreements necessitates solving critical issues such as license rights, confidentiality, IP rights management, or lack of visible profit.
An example of a crucial issue for a private partner providing access to a compound or technology is the definition of the field and territory in which the rights may be granted. Indeed, such rights are restricted to the neglected diseases DNDi intend to address (the field), the countries in which these rights are claimed (territory), and the type of market in which the drug will be distributed (public vs private). By very clearly defining these terms at the initiation of the discussions, the partner obtains the insurance that outside of these sharp boundaries, in which profit is intrinsically impossible, any other opportunities to enter into a private, profit-driven market is secured for the partner, while providing DNDi with all the freedom required to operate before investing large resources to develop a programme.
When negotiating license rights, DNDi highlights to the partner that drugs destined to treat the most neglected diseases must be provided to the patients at minimal costs. For this reason, the typical monetary counterparts, such as royalties or upfront payments to access a license, are not acceptable conditions, as they would render the price of the drug inaccessible to the targeted population. In addition, the licensor has to accept to sub-license it to a third party to allow for manufacturing, as DNDi will outsource these activities.
Thus the absence of conventional counterparts for license rights is countered by the upside the partner will obtain through the efforts of DNDi in further developing the compound or test-proofing the technology. Indeed, DNDi claims no intellectual property rights on discoveries made during the collaboration unless such rights are believed necessary to protect DNDi's patients interests (see DNDi's IP Policy). If the partner wishes to file for a patent on a joint discovery, it has the right to do so, as long as it grants DNDi the necessary rights to develop and distribute the drug to the patients in the field of neglected diseases.
Finally, because DNDi works with many partners, it must ensure maximum confidentiality as well as careful management of existing IP rights in order to create the climate of confidence needed to establish a fruitful partnership.
Reciprocal benefits warranted
Whereas agreements with service providers (fee for service) are straightforward, some creative thinking is thus required to identify mutual benefits when dealing with private partners, or universities' technology transfer offices.
It is important that the partner be entitled to obtain a measurable advantage from its interaction with DNDi, as it is the best condition to create a productive partnership. Depending on the characteristics of the partner and the nature of what it brings into the agreement, such advantages can be as diverse as favourable public image to work in association with a PDP, scientific information generated by DNDi on a particular technology or compound (i.e. early stage development risks endorsed by DNDi), access to R&D grants through joint application, or an increase in the company employee's motivation.
Based on the above principles, DNDi has been able to secure several partnerships with the private sector (i.e GSK, Anacor) as well as with academia. It is a clear demonstration that non-conventional deal structures can be developed which satisfy both PDPs and private partners. However, many creative efforts are still needed to develop contractual guidelines incorporating both the concerns of PDP's in term of access rights and the requirements of the industrial partners. This would certainly greatly help to speed up the discussion and conclusion of agreements with the private sector.